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Completed

NCT Number: NCT05119127

Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome.

The purpose of this research is to assess the rotational stability of the AcrySof IQ Vivity Extended Vision Toric IOL and Refractive Visual outcome.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Florida Eye Specialists

DeLand, Florida, 32720, United States

About this study

Assessment of the rotational stability and Refractive Visual Outcome of the AcrySof IQ Vivity Extended Vision Toric IOL at the end of surgery, post op 1 day, post op 1 week and post op 4 weeks. Participants in this research study are 45 years of age or older and have planned implantation in at least one eye.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects undergoing cataract extraction with intraocular lens implantation.
  • Age: 45 years and older.
  • Willing and able to comply with scheduled visits and other study procedures.
  • Subjects who require an IOL power in the range of +15.0 D to +25.0 D.
  • Subjects with regular corneal astigmatism that can be treated with T3-T5.
  • Have good ocular health, with no pathology that compromises visual acuity (Outside of residual refractive error and cataract)
  • Potential postoperative visual acuity of 0.2 logMAR/ETDRS (20/32 Snellen) or better in both eyes.

Exclusion criteria

  • Glaucoma.
  • Clinically significant corneal dystrophy.
  • Previous corneal refractive surgery (i.e LASIK, PRK, RK)
  • Pupil abnormalities.
  • Concurrent infectious/non-infectious uveitis.
  • History of chronic intraocular inflammation.
  • Visually significant macular disease.
  • History of retinal detachment.

Treatment and study plan

Alcon Vivity toric intra ocular lens

Device

implanting vivity toric IOL to asses rotational stability. IOL is already FDA approved for implantation at time of cataract surger. Intervention is to assess rotational stability and visual outcome.

Primary outcomes

  1. Rotational stability of Vivity Toric IOL.

    Time frame: Five months

    Rotational stability of Vivity Toric IOL will be measured at post op 1 day, post op 1 week and post op 4 weeks.

Secondary outcomes

  1. Percentage of eyes with residual refractive astigmatism, absolute residual astigmatism prediction error, and monocular distance and intermediate visual acuities.

    Time frame: Five months

    Percentage of eyes with post op rotation of five degrees or less, absolute prediction of error ≤ 0.5 D, residual astigmatism ≤ 0.5 D, residual astigmatism 1.00 D.

    Monocular and Binocular UDVA, UIVA, UNVA, CDVA, DCIVA and DCNVA.

Sponsors and collaborators

Lead sponsor

Kevin Barber

Other

Collaborators

  • Alcon Research
  • Eric Rosenberg, D.O.,M.Sc.Eng.

Registry information

Official study title

The Purpose of This Research is to Assess Vivity Toric IOL Rotational Stability at the End of Surgery, Post op 1 Day, Post op 1 Week and Post op 4 Weeks. Participants in This Research Study Are 45 Years of Age or Older and Have Planned Implantation in at Least One Eye With an Acrysof IQ Vivity Extended Vision Toric IOL.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2021
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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